From IND-Enabling Work to First-in-Human: What FDA’s Expedited IND Pilot Says About Integrated Drug Development

Moving a promising drug or biologic from discovery into a first-in-human clinical trial requires much more than preparing an Investigational New Drug application. Nonclinical studies, chemistry, manufacturing and controls (CMC), clinical protocol development, regulatory strategy, Institutional Review Board activities, site readiness, contracting, and other operational activities must come together at the right time. When these workstreams are managed sequentially or without clear dependencies, delays in one area can quickly affect the entire development program.

In September 2026, the U.S. Food and Drug Administration launched its Expedited Investigational New Drug Pilot Program, an initiative under HHS Operation TrialBlazer designed to evaluate new approaches for accelerating first-in-human clinical trials in the United States while maintaining FDA standards for participant safety and scientific oversight.

The pilot introduces a different model for early development. Participating sponsors will work with prospective Qualified Research Institutions (QRIs) that provide multidisciplinary scientific input across nonclinical, CMC, and clinical disciplines. FDA will then accept and review certain IND components on a rolling basis during the pre-IND period as those components are completed.

For pharmaceutical and biotechnology organizations, the pilot provides a useful example of a broader development principle: reaching first-in-human efficiently depends not only on regulatory review timelines, but also on how effectively the activities leading to the IND and clinical trial are integrated.

Understanding the Expedited IND Pilot

FDA launched the Expedited IND Pilot on September 15, 2026, and is accepting applications through October 30, 2026. The pilot is intended to evaluate whether a collaborative development model can reduce the time between initiation of IND-enabling activities and first-in-human trial initiation.

Participating sponsors will partner with a prospective QRI that can provide scientific and regulatory expertise across the major disciplines supporting a first-in-human IND, including pharmacology and toxicology, CMC, and clinical development. FDA describes QRIs as scientific partners that can help sponsors develop phase-appropriate data packages, identify potential gaps or safety concerns earlier, and provide recommendations as IND components are prepared.

The agency expects to initially select approximately eight to ten sponsor-QRI pairs representing a range of therapeutic areas, modalities, sponsor sizes, and QRI types.

Importantly, sponsors retain ownership of and responsibility for their IND submissions throughout the process.

Rolling Review Begins Before the Formal IND Review

One of the most important aspects of the pilot is the distinction between the rolling pre-IND process and FDA’s formal IND review. Under the pilot, participating sponsors may submit discipline-specific components to their pre-IND file as those components become ready. FDA can review those components before the complete IND package is submitted.

FDA is not prescribing one universal sequence for these submissions. The order can reflect the individual development program and recommendations from the sponsor’s QRI.

Before a component is submitted, the QRI is expected to evaluate whether it contains scientifically sound rationale and data and provide the sponsor with actionable feedback where necessary.

This creates opportunities for scientific or regulatory questions to be identified while development is still underway rather than emerging for the first time during the formal IND review. The formal statutory review period, however, does not disappear. Once the required components are complete and relevant earlier feedback has been addressed, the sponsor submits the final IND. That complete submission begins the formal 30-day IND review period. The pilot therefore should not be interpreted as eliminating the standard IND review process. It changes how selected sponsors may interact with FDA and obtain feedback before that formal review begins.

Phase-Appropriate Development Matters

The pilot also highlights the importance of phase-appropriate evidence. Early clinical development does not necessarily require the same level of information that will ultimately be expected later in the product lifecycle. At the same time, the evidence supporting a first-in-human study must be sufficient to address the scientific and safety questions relevant to initiating human exposure. FDA has specifically identified multidisciplinary expertise in nonclinical development, CMC, and clinical planning as central to the QRI model.

For nonclinical development, this includes determining whether pharmacology and toxicology packages are fit for purpose, identifying potential safety concerns, and supporting decisions such as starting-dose selection.

For CMC, the focus includes process and analytical development, characterization strategies, identification of critical CMC gaps, and development of an IND package that is appropriate for the stage of development.

The regulatory challenge is therefore not simply producing more information.

It is determining what information is scientifically necessary and appropriate for the development stage and ensuring that the different components collectively support safe progression into clinical testing.

CMC, Nonclinical, and Clinical Development Cannot Operate Independently

Although IND submissions are organized into distinct technical disciplines, the development program itself is interconnected. Nonclinical findings can influence clinical starting dose, escalation strategy, safety monitoring, and protocol design. CMC decisions can influence the material available for toxicology studies and clinical trials, product comparability considerations, specifications, analytical methods, stability planning, and clinical supply.

Clinical objectives influence what information must be available before dosing begins.

Regulatory strategy connects these activities by defining the evidence needed to support the proposed clinical investigation and identifying when FDA interaction may be valuable.

When these functions operate independently, teams may complete significant work only to discover that another workstream requires additional information, a different sequence, or a change in strategy. Integrated planning allows those dependencies to be identified earlier.

Regulatory Readiness Is Only Part of First-in-Human Readiness

Another important aspect of FDA’s pilot is its attention to activities that occur outside the IND submission itself. FDA specifically identifies IRB review and clinical trial site activation as activities that may, where appropriate, be coordinated alongside IND development and FDA review. This distinction is significant. A program can be regulatory-ready without being operationally ready to dose the first participant.

Even after an IND is allowed to proceed, study initiation can be delayed by site contracting, IRB activities, clinical supply, site activation, investigator readiness, training, laboratory or pharmacy setup, or other operational dependencies. If those activities begin only after regulatory milestones are completed, the overall timeline to first patient dosed may remain unnecessarily long. An integrated first-in-human plan therefore needs to consider both regulatory readiness and clinical execution readiness.

Parallel Planning Does Not Mean Eliminating Controls

Parallel execution can improve timelines, but it needs to be deliberate.

Activities should not simply be started earlier because doing so appears to shorten a schedule.

Teams need to understand which activities can appropriately proceed in parallel, which decisions depend on earlier evidence, and what risks are created when work begins before another milestone is complete.

For example, advancing certain site-startup activities before final regulatory clearance may reduce time to activation, but the organization must understand the financial and operational exposure if the clinical program changes. Similarly, manufacturing clinical material before every development uncertainty is resolved may be appropriate in some programs, but only when the organization understands and accepts the associated risks.

Effective acceleration therefore depends on risk-based decision-making. The objective is not to eliminate sequence where sequence is necessary. It is to identify unnecessary waiting and distinguish it from dependencies that exist for scientific, regulatory, quality, or patient-safety reasons.

The Integrated Development Plan Becomes Critical

The FDA pilot reinforces the value of an integrated development plan that connects the major workstreams required to reach first-in-human testing.

For an early development program, this may include nonclinical studies, CMC development, analytical activities, clinical supply, regulatory interactions, protocol development, IND preparation, IRB activities, contracting, site activation, and clinical operations.

The plan should identify more than target completion dates. It should show dependencies, decision points, regulatory interactions, evidence requirements, resource constraints, critical-path activities, and key program risks. This provides leadership and cross-functional teams with a common view of what actually determines first-in-human readiness. It also creates an opportunity to identify where activities can appropriately proceed in parallel and where an unresolved issue could affect multiple downstream workstreams.

Managing the Interfaces Between Workstreams

In complex development programs, delays frequently occur at the interfaces between functions. A toxicology study may be scheduled, but the required test article must first be manufactured and characterized. A clinical protocol may be drafted, but dose selection may depend on nonclinical data that are still being generated.

A site may be identified, but activation may depend on contracting, IRB review, clinical supply, training, and final protocol readiness. An IND component may be technically complete within one function but still require information or decisions from another. These interfaces need active management.

Cross-functional program governance should therefore focus not only on whether individual deliverables are on schedule, but also on whether the inputs required by the next activity will be available when needed. That distinction can make the difference between a schedule that looks complete and a development plan that is actually executable.

Early Regulatory Engagement Can Reduce Late Surprises

Another principle reflected in the pilot is the value of identifying regulatory and scientific questions before the final IND is submitted.

The rolling model allows FDA to review discipline-specific components during the pre-IND period, creating opportunities for questions to be identified and addressed earlier.

For sponsors outside the pilot, the mechanism may be different, but the underlying principle remains relevant. FDA specifically notes that sponsors not selected for the pilot can continue to use established regulatory interactions, including INTERACT and pre-IND meetings, as appropriate.

The important consideration is whether the development team has identified the questions that materially affect the program and seeks regulatory feedback at a point when that feedback can still influence development decisions. Regulatory interactions create the most value when they are connected to decision-making rather than treated simply as milestones on a project schedule.

What Pharmaceutical and Biotechnology Organizations Should Consider

FDA’s Expedited IND Pilot provides an opportunity for organizations to examine how they manage early development even if they never participate in the program. Teams should consider whether nonclinical, CMC, clinical, regulatory, and clinical-operations plans are truly integrated or simply maintained as separate functional schedules.

Organizations should understand the dependencies that determine first-in-human readiness and identify which activities can appropriately occur in parallel. Regulatory questions that could materially affect development should be identified early enough for meaningful agency interaction.

Clinical startup planning should also begin early enough that IRB review, contracting, site readiness, clinical supply, and other operational activities do not unnecessarily delay study initiation after the IND can proceed.

Most importantly, teams should distinguish between acceleration and compression.

Acceleration comes from better planning, earlier issue identification, appropriate parallel execution, phase-appropriate evidence generation, and timely decision-making.

Simply compressing timelines without understanding dependencies and risk can create the opposite result.

Looking Ahead

FDA describes the Expedited IND initiative as a pilot designed to generate evidence about whether the QRI model and rolling pre-IND review can improve submission quality, regulatory efficiency, and early clinical-development timelines.

The agency has also indicated that experience from the program could inform future approaches to modernizing FDA support for early-stage clinical development. That possibility makes the pilot worth monitoring beyond the organizations selected for the initial cohort. However, the program should not be interpreted as a new regulatory pathway or a reduction in FDA’s standards for first-in-human studies.

Participation is voluntary. FDA retains full regulatory authority, including responsibility for determining whether a clinical investigation may proceed and whether a clinical hold is necessary. Participation does not modify the statutory or regulatory standards governing IND review or clinical trial conduct.

For Regulatory and development professionals, the more immediate lesson is operational.

Faster development does not necessarily come from doing less. It can come from identifying the right work earlier, connecting the functions responsible for delivering it, resolving critical questions sooner, and eliminating avoidable waiting between activities.

That principle applies well beyond this pilot.

About OneGlobal Trinity M Consulting

OneGlobal Trinity M Consulting supports medical device, pharmaceutical, and biotechnology organizations navigating complex regulatory, quality, clinical, product development, validation, and program execution challenges.

We work with organizations to connect strategy with execution, helping cross-functional teams align regulatory requirements, development activities, evidence needs, project timelines, risks, and key decisions throughout the product lifecycle. Our experience across global life sciences programs enables us to support organizations as they navigate evolving regulatory expectations, complex development initiatives, and the operational challenges associated with bringing products to market.

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References

• U.S. Food and Drug Administration. FDA Expedited Investigational New Drug (IND) Pilot Program. 2026.

• U.S. Food and Drug Administration. Expedited IND Rolling Submission Process and Program Structure. 2026.

• U.S. Food and Drug Administration. Expedited Investigational New Drug Pilot Program – Application Instructions. 2026.

• U.S. Food and Drug Administration. FDA Launches Expedited IND Pilot, Begins Accepting Applications. September 15, 2026.

• U.S. Food and Drug Administration. FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development. 2026.

Regulatory Note

The Expedited IND Pilot is a voluntary FDA pilot program. Participation does not change the statutory or regulatory standards applicable to IND review, clinical-hold determinations, or clinical-trial conduct. Sponsors remain responsible for their IND submissions, and FDA retains full regulatory authority throughout the process.